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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
QuintilesIMS
Chubb
Merck
Colorcon
Cipla
Deloitte
McKinsey

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021636

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NDA 021636 describes ZEGERID, which is a drug marketed by Santarus Inc, Santarus, and Bayer Healthcare Llc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the ZEGERID profile page.

The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and thirty-eight drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.
Summary for 021636
Tradename:ZEGERID
Applicant:Santarus Inc
Ingredient:omeprazole; sodium bicarbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021636
Suppliers and Packaging for NDA: 021636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636 NDA Santarus, Inc.. 68012-052 N 68012-052-30
ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636 NDA Santarus, Inc.. 68012-054 N 68012-054-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength20MG/PACKET;1.68GM/PACKET
Approval Date:Jun 15, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/PACKET;1.68GM/PACKET
Approval Date:Dec 21, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021636

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ➤ Sign Up ➤ Sign Up
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Sign Up ➤ Sign Up
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Sign Up ➤ Sign Up
Santarus Inc ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
UBS
Medtronic
Deloitte
Citi
Cipla
Queensland Health
Teva

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