Treats Symptomatic GERD. ANDA 204237, held by Rubicon Research. Rabeprazole Sodium.
As of Nov 15, 2026, ANDA 204237 (Rabeprazole Sodium), held by Rubicon Research, was first approved by FDA on Nov 18, 2015, with 6 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rabeprazole Sodium20MG · tablet, delayed release;oral | Rabeprazole Sodium | Rx |
| Jun 5, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 30, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 30, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 29, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 29, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 29, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 18, 2015 | Original application | Approved | None posted |
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
