Details for New Drug Application (NDA): 021689

NDA 021689 describes NEXIUM IV, which is a drug marketed by Astrazeneca and is included in one NDA. 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. Two 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

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		Strength	EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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		Strength	EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Mar 31, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021689

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	5,877,192*PED
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	6,143,771
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005	6,143,771
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	5,877,192*PED

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