Rabeprazole Sodium

ANDA 76885, held by Pharmobedient. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 76885 (Rabeprazole Sodium), held by Pharmobedient, was first approved by FDA on Nov 8, 2013, with 8 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

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

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Oct 31, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Oct 31, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 8, 2013	Original application	Approved	Label Letter Letter

Identifiers

Application: ANDA 76885
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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