Pantoprazole Sodium

ANDA 90807, held by Rubicon Research. Pantoprazole Sodium.

As of Nov 15, 2026, ANDA 90807 (Pantoprazole Sodium), held by Rubicon Research, was first approved by FDA on May 2, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: May 2, 2012
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
May 2, 2012	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 11 submissions, including labeling and manufacturing supplements


Sep 22, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Nov 13, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 13, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 13, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 13, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Nov 13, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Apr 8, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Dec 13, 2014	Supplement 2Labeling · Standard review	Approved	None posted
May 30, 2013	Supplement 1Labeling · Standard review	Approved	None posted
May 2, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90807
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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