Pantoprazole Sodium

ANDA 91231, held by Apotex. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 91231 (Pantoprazole Sodium), held by Apotex, was first approved by FDA on Jan 19, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 19, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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 2 submissions, including labeling and manufacturing supplements


May 27, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jan 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91231
Drugs@FDA: Overview at FDA
Company: Apotex

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