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Serving leading biopharmaceutical companies globally:

Deloitte
Novartis
McKesson
Healthtrust
Farmers Insurance
Federal Trade Commission
Daiichi Sankyo
Cantor Fitzgerald
US Department of Justice
Harvard Business School

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075347

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NDA 075347 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-one 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 075347
Tradename:OMEPRAZOLE
Applicant:Actavis Labs Fl Inc
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075347
Medical Subject Heading (MeSH) Categories for 075347
Suppliers and Packaging for NDA: 075347
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075347 ANDA KAISER FOUNDATION HOSPITALS 0179-0016 0179-0016-70 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOX, UNIT-DOSE (0179-0016-70)
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075347 ANDA Golden State Medical Supply, Inc. 60429-899 60429-899-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (60429-899-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:May 30, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:May 30, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:May 30, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
McKesson
Harvard Business School
Chubb
Boehringer Ingelheim
UBS
US Army
Citi

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