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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214278

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NDA 214278 describes ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Cipla, P And L, and Dexcel, and is included in forty-four NDAs. It is available from one hundred and ten 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 twelve suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for 214278

Tradename:	ESOMEPRAZOLE MAGNESIUM
Applicant:	Dexcel
Ingredient:	esomeprazole magnesium
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Oct 20, 2020	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 8, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 8, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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