Treats Symptomatic GERD. ANDA 208644, held by Alkem Labs Ltd. Rabeprazole Sodium.
As of Nov 15, 2026, ANDA 208644 (Rabeprazole Sodium), held by Alkem Labs Ltd, was first approved by FDA on Apr 24, 2018, with 5 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 |
|---|---|---|---|
| Apr 24, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rabeprazole Sodium20MG · tablet, delayed release;oral | Rabeprazole Sodium | Rx |
| Oct 31, 2023 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 2, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 14, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 14, 2021 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 19, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 24, 2018 | 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
