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As of Nov 15, 2026, ANDA 216021 (Pantoprazole Sodium), held by Fresenius Kabi USA, was first approved by FDA on Aug 1, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Aug 1, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE).
Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome. 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
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
