ANDA 215860, held by Meitheal. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 215860 (Pantoprazole Sodium), held by Meitheal, was first approved by FDA on Aug 29, 2022, with 3 approved supplements and 0 published complete response letters.
Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pantoprazole SodiumEQ 40MG BASE/VIAL · injectable;intravenous | Pantoprazole Sodium | Rx |
| Jun 15, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 15, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 1, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 29, 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
