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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 210070

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NDA 210070 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Pharmobedient, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma Intl, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Marksans Pharma, and P And L, and is included in forty-seven NDAs. It is available from ninety-three suppliers. There are three 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. Fifty-four suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 210070

Tradename:	OMEPRAZOLE
Applicant:	Apotex
Ingredient:	omeprazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 210070

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Feb 11, 2019	TE:		RLD:	No

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