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Last Updated: October 28, 2020

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Details for New Drug Application (NDA): 075410

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NDA 075410 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, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Zydus Pharms, Spil, and P And L, and is included in forty-three NDAs. It is available from eighty-four 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-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 075410
Tradename:OMEPRAZOLE
Applicant:Lannett Co Inc
Ingredient:omeprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075410
Medical Subject Heading (MeSH) Categories for 075410
Suppliers and Packaging for NDA: 075410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075410 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-829 43353-829-60 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60)
OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075410 ANDA A-S Medication Solutions 50090-0828 50090-0828-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Nov 1, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Nov 1, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 23, 2009TE:ABRLD:No

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