Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)…. ANDA 217416, held by Ajanta Pharma Ltd. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 217416 (Pantoprazole Sodium), held by Ajanta Pharma Ltd, was first approved by FDA on Feb 9, 2023, with 1 approved supplement and 0 published complete response letters.
Pantoprazole sodium for delayed-release oral suspension is indicated for: Pantoprazole sodium for delayed-release oral suspension is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) Maintenance of Healing of Erosive Esophagitis Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pantoprazole SodiumEQ 40MG BASE · for suspension, delayed release;oral | Pantoprazole Sodium | Rx |
| Apr 23, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 9, 2023 | 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
