Zegerid

NDA 21706, held by Santarus. Omeprazole; Sodium Bicarbonate.

As of Nov 14, 2026, NDA 21706 (Zegerid), held by Santarus, was first approved by FDA on Dec 21, 2004, with 0 approved supplements and 0 published complete response letters.

• First approved: Dec 21, 2004
• Review: Standard
• Supplements approved: 0
• Complete response letters: 0

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