Details for New Drug Application (NDA): 021689

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NDA 021689 describes NEXIUM IV, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the NEXIUM IV profile page.

The generic ingredient in NEXIUM IV 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 021689

Tradename:	NEXIUM IV
Applicant:	Astrazeneca
Ingredient:	esomeprazole sodium
Patents:	0

Pharmacology for NDA: 021689

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 021689

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689	NDA	AstraZeneca Pharmaceuticals LP	0186-6040	0186-6040-01	10 VIAL in 1 CARTON (0186-6040-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 31, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 40MG BASE/VIAL
Approval Date:	Mar 31, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021689

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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