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Last Updated: December 11, 2025

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 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 215732

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Slate Run Pharma
Ingredient:	esomeprazole sodium
Patents:	0

Pharmacology for NDA: 215732

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 215732

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	215732	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-060	14335-060-01	10 VIAL in 1 CARTON (14335-060-01) / 5 mL in 1 VIAL
ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	215732	ANDA	Slate Run Pharmaceuticals, LLC	70436-190	70436-190-82	10 VIAL in 1 CARTON (70436-190-82) / 5 mL in 1 VIAL (70436-190-80)

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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