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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215732

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NDA 215732 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 two 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. Two suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 215732

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Slate Run Pharma
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:	Feb 10, 2022	TE:	AP	RLD:	No

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