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US Department of Justice
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Generated: August 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076515

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NDA 076515 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, Mylan Pharms Inc, 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-five NDAs. It is available from one hundred and ten 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-seven suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 076515
Tradename:OMEPRAZOLE
Applicant:Sandoz
Ingredient:omeprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076515
Medical Subject Heading (MeSH) Categories for 076515
Suppliers and Packaging for NDA: 076515
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 076515 ANDA Sandoz Inc 0781-2234 N 0781-2234-01
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 076515 ANDA Sandoz Inc 0781-2234 N 0781-2234-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 21, 2009TE:ABRLD:No

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