Treats Symptomatic GERD. ANDA 205761, held by Quagen. Rabeprazole Sodium.
As of Nov 15, 2026, ANDA 205761 (Rabeprazole Sodium), held by Quagen, was first approved by FDA on Feb 17, 2017, with 5 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rabeprazole Sodium20MG · tablet, delayed release;oral | Rabeprazole Sodium | Rx |
| Oct 31, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 14, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 30, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 1, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 1, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 17, 2017 | 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
