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Baxter
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Dow
Fuji
US Department of Justice
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091352

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NDA 091352 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 091352
Tradename:OMEPRAZOLE
Applicant:Zydus Pharms Usa Inc
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091352
Medical Subject Heading (MeSH) Categories for 091352
Suppliers and Packaging for NDA: 091352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091352 ANDA Cadila Healthcare Limited 65841-759 N 65841-759-16
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091352 ANDA Cadila Healthcare Limited 65841-759 N 65841-759-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Nov 19, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Nov 19, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Nov 19, 2012TE:ABRLD:No

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