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