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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cipla
Daiichi Sankyo
Covington
Chinese Patent Office
Cerilliant
McKesson
Queensland Health
Express Scripts

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022032

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NDA 022032 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, Kremers Urban Pharms, 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 eight 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 022032
Tradename:OMEPRAZOLE
Applicant:Dexcel Pharma
Ingredient:omeprazole
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022032
Suppliers and Packaging for NDA: 022032
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 022032 NDA L. Perrigo Company 0113-0915 N 0113-0915-03
OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 022032 NDA L. Perrigo Company 0113-0915 N 0113-0915-30

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Dec 4, 2007TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 16, 2025Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Mallinckrodt
Baxter
US Department of Justice
Fish and Richardson
Dow
Cantor Fitzgerald
Merck

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