Rabeprazole Sodium

Treats Symptomatic GERD. ANDA 202376, held by Torrent. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 202376 (Rabeprazole Sodium), held by Torrent, 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

What It's For

From the FDA-approved label (Indications and Usage)

Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD). Maintenance of Healing of Erosive or Ulcerative GERD. Treatment of Symptomatic GERD. Healing of Duodenal Ulcers. Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence. Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. In adolescent patients 12 years of age and older for: Short-term Treatment of Symptomatic GERD. 1.

Full prescribing information on DailyMed ↗

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	None posted

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


Apr 23, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Sep 2, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Sep 14, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Nov 30, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Nov 30, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Nov 30, 2018	Supplement 13Labeling · Standard review	Approved	None posted
Nov 30, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Apr 2, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Apr 2, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Nov 8, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202376
Drugs@FDA: Overview at FDA
Company: Torrent 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