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Last Updated: January 24, 2021

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Details for New Drug Application (NDA): 205070

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NDA 205070 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Cumberland Pharms, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Unicorn, Zydus Pharms, Spil, and P And L, and is included in forty-three NDAs. It is available from eighty-one suppliers. There are two patents 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 thirty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 205070
Tradename:OMEPRAZOLE
Applicant:Mylan
Ingredient:omeprazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205070

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Jun 29, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Jun 29, 2018TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jun 29, 2018TE:RLD:No

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