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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214046

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NDA 214046 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 214046

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Epic Pharma Llc
Ingredient:	esomeprazole sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Jan 8, 2025	TE:	AP	RLD:	No

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