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Zegerid Approval History

FDA Approved: Yes (First approved June 15, 2004)
Brand name: Zegerid
Generic name: omeprazole and sodium bicarbonate
Previous Name: Rapinex
Company: Santarus, Inc.
Treatment for: Duodenal Ulcer, GERD, Stomach Ulcer, Erosive Esophagitis

Zegerid (omeprazole and sodium bicarbonate) is proton-pump inhibitor and antacid combination for the treatment of duodenal ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), and erosive esophagitis.

Development History and FDA Approval Process for Zegerid

DateArticle
Feb 24, 2006Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA
Jul 26, 2005Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets
Jun 28, 2005Santarus Announces FDA Acceptance of New Drug Application For Zegerid Capsules; FDA Action Expected in Early 2006 on NDA for First Immediate-Release Proton Pump Inhibitor in Capsule Formulation
May 27, 2005Santarus Submits New Drug Application for Zegerid Chewable Tablets
Apr 28, 2005Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target
Jun 15, 2004Approval Zegerid Santarus, Inc. - Treatment for Heartburn/GERD, Erosive Esophagitis, Duodenal Ulcers
Apr 29, 2004FDA Accepts for Filing Santarus' New Drug Application for Rapinex Powder for Oral Suspension 40mg

Further information

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