Pantoprazole Sodium

ANDA 211368, held by Ingenus Pharms LLC. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 211368 (Pantoprazole Sodium), held by Ingenus Pharms LLC, was first approved by FDA on Mar 1, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 1, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 1, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pantoprazole SodiumEQ 40MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 27, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Jun 9, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Jun 9, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Dec 20, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Mar 1, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 211368
Drugs@FDA: Overview at FDA
Company: Ingenus 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