Pantoprazole Sodium

ANDA 77056, held by Teva. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 77056 (Pantoprazole Sodium), held by Teva, was first approved by FDA on Aug 2, 2007, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2007
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Aug 2, 2007	Original application	Approved	Letter

Products

2 strengths and forms


Pantoprazole SodiumEQ 20MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	Discontinued
Pantoprazole SodiumEQ 40MG BASE · tablet, delayed release;oral	Pantoprazole Sodium	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Aug 11, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 20Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Aug 11, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 15Labeling · Standard review	Approved	None posted
May 3, 2013	Supplement 10Labeling · Standard review	Approved	None posted
Oct 3, 2012	Supplement 8Labeling	Approved	None posted
Oct 3, 2012	Supplement 9Labeling · Standard review	Approved	None posted
Jul 31, 2011	Supplement 7Labeling	Approved	None posted
Mar 31, 2011	Supplement 5Labeling	Approved	None posted
Mar 31, 2011	Supplement 6Labeling	Approved	None posted
May 21, 2009	Supplement 3Labeling	Approved	None posted
Aug 2, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77056
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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