FDA Approved: BERKLEY AND JENSEN OMEPRAZOLE — Supplemental Application (BJWC)

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Summary

FDA approved a supplemental application for Berkley and Jensen Omeprazole (omeprazole). This approval supports updates to labeling and expanded uses.

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Diseases / indications

• Duodenal Ulcer
• Erosive Esophagitis
• Gastric Ulcer
• Gastroesophageal Reflux Disease
• Helicobacter Pylori Infection
• Zollinger-ellison Syndrome

Drugs mentioned

• BERKLEY AND JENSEN OMEPRAZOLE (omeprazole)

Snippet

SUPPL AP for BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE)