Details for New Drug Application (NDA): 204655

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NDA 204655 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 ten suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for 204655

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

Pharmacology for NDA: 204655

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 204655

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655	NDA	Haleon US Holdings LLC	0573-2450	0573-2450-02	1 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655	NDA	Haleon US Holdings LLC	0573-2450	0573-2450-14	1 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Mar 28, 2014	TE:		RLD:	Yes

Expired US Patents for NDA 204655

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	6,369,085*PED	⤷ Subscribe
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	5,690,960*PED	⤷ Subscribe
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	6,875,872*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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