Rabeprazole Sodium

ANDA 78964, held by Chartwell Rx. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 78964 (Rabeprazole Sodium), held by Chartwell Rx, was first approved by FDA on Nov 8, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2013
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
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	Rx

All 10 submissions, including labeling and manufacturing supplements


Oct 31, 2023	Supplement 23Labeling · Standard review	Approved	None posted
May 8, 2023	Supplement 18Labeling · Standard review	Approved	None posted
May 8, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Feb 1, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 8, 2013	Original application	Approved	Label Letter

Identifiers

Application: ANDA 78964
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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