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
|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|| 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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