Pantoprazole Sodium

ANDA 90296, held by Sandoz. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 90296 (Pantoprazole Sodium), held by Sandoz, was first approved by FDA on Jul 14, 2015, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2015
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 14, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Oct 1, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Jul 28, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Mar 5, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jul 14, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 90296
Drugs@FDA: Overview at FDA
Company: Sandoz

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