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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Colorcon
Accenture
Baxter
Johnson and Johnson
Citi
Covington
Chubb
McKinsey

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091672

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NDA 091672 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Gastroentero, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc, and is included in thirty-two NDAs. It is available from one hundred and nine suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the OMEPRAZOLE profile page.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 091672
Tradename:OMEPRAZOLE
Applicant:Glenmark Generics
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091672
Medical Subject Heading (MeSH) Categories for 091672
Suppliers and Packaging for NDA: 091672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091672 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8079 N 0615-8079-05
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091672 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8079 N 0615-8079-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Oct 31, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
US Army
Cerilliant
Fuji
Deloitte
Chubb
QuintilesIMS
Medtronic

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