Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209716

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NDA 209716 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, 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 thirteen 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 is one drug master file entry for this compound. One hundred and fifteen suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for 209716

Tradename:	ESOMEPRAZOLE MAGNESIUM
Applicant:	Amneal Pharms Ny
Ingredient:	esomeprazole magnesium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 5, 2019	TE:		RLD:	No

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