Treats Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)…. ANDA 215880, held by Mankind Pharma. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 215880 (Pantoprazole Sodium), held by Mankind Pharma, was first approved by FDA on Jul 26, 2022, with 1 approved supplement and 0 published complete response letters.
Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium 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 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2022 | Original application | Approved | None posted |
| Pantoprazole SodiumEQ 40MG BASE · tablet, delayed release;oral | Pantoprazole Sodium | Rx |
| Pantoprazole SodiumEQ 20MG BASE · tablet, delayed release;oral | Pantoprazole Sodium | Discontinued |
| Sep 18, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 26, 2022 | 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
