Pantoprazole Sodium

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). ANDA 216139, held by Annora Pharma. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 216139 (Pantoprazole Sodium), held by Annora Pharma, was first approved by FDA on Oct 27, 2023, with 0 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole sodium for delayed-release oral suspension is 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 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium 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

Date	Submission	Status	Documents
Oct 27, 2023	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pantoprazole SodiumEQ 40MG BASE · for suspension, delayed release;oral	Pantoprazole Sodium	Rx

Identifiers

Application: ANDA 216139
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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