Pantoprazole Sodium

ANDA 202052, held by Orbion Pharms. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 202052 (Pantoprazole Sodium), held by Orbion Pharms, was first approved by FDA on Dec 2, 2014, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 2, 2014
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
Dec 2, 2014	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 10 submissions, including labeling and manufacturing supplements


Apr 16, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Aug 15, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Aug 15, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jul 22, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Jul 22, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Jul 22, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jul 22, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jul 22, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Dec 2, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202052
Drugs@FDA: Overview at FDA
Company: Orbion 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