Pantoprazole Sodium

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)…. ANDA 78281, held by Lannett Co Inc. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 78281 (Pantoprazole Sodium), held by Lannett Co Inc, was first approved by FDA on Jan 20, 2011, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 20, 2011
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole 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 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole is 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 (EE).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jan 20, 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 19 submissions, including labeling and manufacturing supplements


Sep 27, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Jun 9, 2022	Supplement 32Labeling · Standard review	Approved	None posted
Jan 21, 2022	Supplement 30Labeling · Standard review	Approved	None posted
Jan 21, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Jan 3, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Aug 5, 2014	Supplement 6Labeling	Approved	None posted
Dec 10, 2013	Supplement 15Labeling · Standard review	Approved	None posted
May 24, 2013	Supplement 13Labeling · Standard review	Approved	None posted
May 24, 2013	Supplement 12Labeling · Standard review	Approved	None posted
May 18, 2012	Supplement 11Manufacturing	Approved	None posted
Jan 17, 2012	Supplement 10Labeling	Approved	None posted
Jan 17, 2012	Supplement 8Labeling	Approved	None posted
Jan 20, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78281
Drugs@FDA: Overview at FDA
Company: Lannett Company

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