Rabeprazole Sodium

Treats Symptomatic GERD. ANDA 204179, held by Amneal Pharms. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 204179 (Rabeprazole Sodium), held by Amneal Pharms, was first approved by FDA on Jul 31, 2015, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2015
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Rabeprazole sodium delayed-release tablets are 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 9 submissions below

Date	Submission	Status	Documents
Jul 31, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Nov 5, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 5, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Nov 5, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Nov 5, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Jul 31, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204179
Drugs@FDA: Overview at FDA
Company: Amneal 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