Last Updated: September 24, 2026

Details for New Drug Application (NDA): 200882

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NDA 200882 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 200882

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Sun Pharm
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:	Mar 18, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Mar 18, 2013	TE:		RLD:	No

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