Last Updated: September 24, 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, 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 215732

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Hainan Poly
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	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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