FDA Tentative Approval: PANTOPRAZOLE SODIUM — Supplemental Application (Civica, Inc.)

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Summary

The FDA issued tentative approval for Civica, Inc.'s pantoprazole sodium supplemental application (NDA 209463), enabling tentative U.S. marketing approval for a…

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Diseases / indications

• Duodenal Ulcer
• Erosive Esophagitis
• Gastric Ulcer
• Gastroesophageal Reflux Disease

Drugs mentioned

• Pantoprazole sodium (pantoprazole sodium)

Snippet

SUPPL TA for PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)