Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205379

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NDA 205379 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Hainan Poly, Pharmobedient, and Sun Pharm, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 205379

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Accord Hlthcare
Ingredient:	esomeprazole sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Sep 25, 2015	TE:		RLD:	No

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