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Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075757

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NDA 075757 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 075757
Tradename:OMEPRAZOLE
Applicant:Sandoz
Ingredient:omeprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075757
Medical Subject Heading (MeSH) Categories for 075757
Suppliers and Packaging for NDA: 075757
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075757 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1359 N 0615-1359-05
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075757 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1359 N 0615-1359-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Jan 28, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Jan 28, 2003TE:ABRLD:No

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