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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 202784

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NDA 202784 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cipla, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Perrigo R And D, Pharmobedient, P And L, and Dexcel, and is included in fifty NDAs. It is available from one hundred and twelve suppliers. There are two patents protecting this drug. Additional details are available on the ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and fourteen suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for 202784

Tradename:	ESOMEPRAZOLE MAGNESIUM
Applicant:	Hetero Labs Ltd Iii
Ingredient:	esomeprazole magnesium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 20MG BASE
Approval Date:	Sep 21, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 40MG BASE
Approval Date:	Sep 21, 2015	TE:		RLD:	No

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