ANDA 204400, held by Gland. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 204400 (Pantoprazole Sodium), held by Gland, was first approved by FDA on May 18, 2022, with 2 approved supplements and 0 published complete response letters.
Pantoprazole sodium for injection is indicated for treatment of: gas troesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. patho logical 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 |
|---|---|---|---|
| May 18, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pantoprazole SodiumEQ 40MG BASE/VIAL · injectable;intravenous | Pantoprazole Sodium | Rx |
| Mar 25, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 18, 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
