Details for New Drug Application (NDA): 022511

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NDA 022511 describes VIMOVO, which is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. Additional details are available on the VIMOVO profile page.

The generic ingredient in VIMOVO is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

Summary for 022511

Tradename:	VIMOVO
Applicant:	Horizon
Ingredient:	esomeprazole magnesium; naproxen
Patents:	0

Pharmacology for NDA: 022511

Mechanism of Action	Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022511

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511	NDA	Horizon Therapeutics USA, Inc.	75987-030	75987-030-04	60 TABLET, DELAYED RELEASE in 1 BOTTLE (75987-030-04)
VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511	NDA	Horizon Therapeutics USA, Inc.	75987-030	75987-030-73	1 BOTTLE in 1 CARTON (75987-030-73) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 30, 2010	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 30, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022511

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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