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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 022101

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NDA 022101 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 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 022101

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

Pharmacology for NDA: 022101

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022101

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101	NDA	AstraZeneca Pharmaceuticals LP	0186-4010	0186-4010-01	30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	EQ 10MG BASE/PACKET
Approval Date:	Feb 27, 2008	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022101

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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