Rabeprazole Sodium

ANDA 76822, held by Teva Pharms USA. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 76822 (Rabeprazole Sodium), held by Teva Pharms USA, was first approved by FDA on Nov 8, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2013
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 8, 2013	Original application	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rabeprazole Sodium20MG · tablet, delayed release;oral	Rabeprazole Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 14, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Dec 4, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Dec 4, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Dec 4, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Dec 4, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Nov 8, 2013	Original application	Approved	Label Letter

Identifiers

Application: ANDA 76822
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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