Pantoprazole Sodium

Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). ANDA 90970, held by Mylan Pharms Inc. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 90970 (Pantoprazole Sodium), held by Mylan Pharms Inc, was first approved by FDA on Jan 19, 2011, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 19, 2011
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:

Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
Maintenance of Healing of Erosive Esophagitis
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 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 14 submissions, including labeling and manufacturing supplements


Nov 16, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Apr 6, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Apr 6, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 16, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Aug 7, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Sep 7, 2012	Supplement 3Labeling	Approved	None posted
Jan 11, 2012	Supplement 2Labeling	Approved	None posted
Jan 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90970
Drugs@FDA: Overview at FDA
Company: Mylan 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