Details for New Drug Application (NDA): 021957

NDA 021957 describes NEXIUM, which is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs. It is available from one supplier. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 021957

Tradename:	NEXIUM
Applicant:	Astrazeneca
Ingredient:	esomeprazole magnesium
Patents:	0

Pharmacology for NDA: 021957

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 021957

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957	NDA	AstraZeneca Pharmaceuticals LP	0186-4020	0186-4020-01	30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4020-01)
NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957	NDA	AstraZeneca Pharmaceuticals LP	0186-4025	0186-4025-01	30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4025-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE/PACKET
Approval Date:	Oct 20, 2006	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 40MG BASE/PACKET
Approval Date:	Oct 20, 2006	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 2.5MG BASE/PACKET
Approval Date:	Dec 15, 2011	TE:	AB	RLD:	Yes

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