Pantoprazole Sodium

ANDA 205675, held by Eugia Pharma. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 205675 (Pantoprazole Sodium), held by Eugia Pharma, was first approved by FDA on Mar 30, 2016, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2016
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole sodium for injection is indicated for treatment of:

gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults.
pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 30, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pantoprazole SodiumEQ 40MG BASE/VIAL · injectable;intravenous	Pantoprazole Sodium	Rx

All 13 submissions, including labeling and manufacturing supplements


Apr 25, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Apr 25, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Jul 28, 2022	Supplement 17Labeling · Standard review	Approved	None posted
Mar 19, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 12Manufacturing	Approved	None posted
Sep 17, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Sep 17, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 17, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Sep 17, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Sep 17, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Mar 30, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205675
Drugs@FDA: Overview at FDA
Company: Eugia 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