FDA Approved: OMEPRAZOLE — Supplemental Application (Sandoz Inc)

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Summary

FDA approved a supplemental application for Omeprazole from Sandoz Inc (ANDA075757). The approval confirms the generic product under the approved terms.

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Diseases / indications

• Duodenal Ulcer
• Erosive Esophagitis
• Gastric Ulcer
• Gastroesophageal Reflux Disease
• Helicobacter Pylori Infection
• Nsaid-associated Gastroduodenal Ulcers

Drugs mentioned

• Omeprazole (Omeprazole)

Snippet

SUPPL AP for OMEPRAZOLE (OMEPRAZOLE)