Details for New Drug Application (NDA): 207920

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NDA 207920 describes NEXIUM 24HR, which is a drug marketed by Astrazeneca Lp and is included in two NDAs. It is available from two suppliers. Additional details are available on the NEXIUM 24HR profile page.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for 207920

Tradename:	NEXIUM 24HR
Applicant:	Astrazeneca Lp
Ingredient:	esomeprazole magnesium
Patents:	0

Pharmacology for NDA: 207920

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 207920

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920	NDA	Haleon US Holdings LLC	0573-2451	0573-2451-14	1 BOTTLE in 1 CARTON (0573-2451-14) / 14 TABLET in 1 BOTTLE
NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920	NDA	Haleon US Holdings LLC	0573-2451	0573-2451-42	3 BOTTLE in 1 BLISTER PACK (0573-2451-42) / 14 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Nov 23, 2015	TE:		RLD:	Yes

Expired US Patents for NDA 207920

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015	⤷ Sign Up	⤷ Sign Up
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015	⤷ Sign Up	⤷ Sign Up
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015	⤷ Sign Up	⤷ Sign Up
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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