Pantoprazole Sodium

ANDA 79197, held by Epic Pharma LLC. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 79197 (Pantoprazole Sodium), held by Epic Pharma LLC, was first approved by FDA on Nov 8, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2012
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 8, 2012	Original application	Approved	Review

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Mar 17, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Mar 17, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Mar 17, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Mar 17, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 24, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Nov 8, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 79197
Drugs@FDA: Overview at FDA
Company: Epic 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