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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 202686

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NDA 202686 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 202686

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Pharmobedient
Ingredient:	esomeprazole sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 20MG BASE/VIAL
Approval Date:	May 17, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	May 17, 2017	TE:		RLD:	No

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