Details for New Drug Application (NDA): 203349

NDA 203349 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Mylan, Slate Run Pharma, and Sun Pharm, and is included in seven 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. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 203349

Tradename:	ESOMEPRAZOLE SODIUM
Applicant:	Gland Pharma Ltd
Ingredient:	esomeprazole sodium
Patents:	0

Pharmacology for NDA: 203349

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 203349

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	203349	ANDA	Gland Pharma Limited	68083-451	68083-451-10	10 VIAL in 1 CARTON (68083-451-10) / 5 mL in 1 VIAL (68083-451-01)
ESOMEPRAZOLE SODIUM	esomeprazole sodium	INJECTABLE;INTRAVENOUS	203349	ANDA	Gland Pharma Limited	68083-452	68083-452-10	10 VIAL in 1 CARTON (68083-452-10) / 5 mL in 1 VIAL (68083-452-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 20MG BASE/VIAL
Approval Date:	Apr 1, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Apr 1, 2020	TE:	AP	RLD:	No

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