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As of Nov 15, 2026, ANDA 209524 (Pantoprazole Sodium), held by Hangzhou Zhongmei, was first approved by FDA on Aug 30, 2021, with 2 approved supplements and 0 published complete response letters.
First approved: Aug 30, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
