Rabeprazole Sodium

Treats Symptomatic GERD. ANDA 90678, held by Lannett Co Inc. Rabeprazole Sodium.

As of Nov 15, 2026, ANDA 90678 (Rabeprazole Sodium), held by Lannett Co Inc, was first approved by FDA on Nov 8, 2013, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2013
Supplements approved: 10
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 the 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 11 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 11 submissions, including labeling and manufacturing supplements


Nov 1, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Nov 1, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Nov 1, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Nov 1, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Feb 7, 2019	Supplement 7Labeling · 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
Apr 3, 2015	Supplement 4Labeling · 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 90678
Drugs@FDA: Overview at FDA
Company: Lannett Company

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