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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204657

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NDA 204657 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Pharmobedient, Slate Run Pharma, and Sun Pharm, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 204657

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Eugia Pharma
Ingredient:	esomeprazole sodium
Patents:	0

Pharmacology for NDA: 204657

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 204657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	204657	ANDA	Eugia US LLC	55150-185	55150-185-05	10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 20MG BASE/VIAL
Approval Date:	Aug 10, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Aug 10, 2016	TE:		RLD:	No

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