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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204152

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NDA 204152 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, Marksans Pharma, P And L, and Perrigo R And D, and is included in nine NDAs. It is available from fifty-two suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 204152

Tradename:	OMEPRAZOLE MAGNESIUM
Applicant:	Perrigo R And D
Ingredient:	omeprazole magnesium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jul 30, 2015	TE:		RLD:	No

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