Details for New Drug Application (NDA): 022425

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NDA 022425 describes MULTAQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MULTAQ profile page.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Summary for 022425

Tradename:	MULTAQ
Applicant:	Sanofi Aventis Us
Ingredient:	dronedarone hydrochloride
Patents:	3

Pharmacology for NDA: 022425

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 022425

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425	NDA	Sanofi-Aventis U.S. LLC	0024-4142	0024-4142-00	6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)
MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425	NDA	Sanofi-Aventis U.S. LLC	0024-4142	0024-4142-06	8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Jul 1, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 16, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS
Patent:	⤷ Sign Up	Patent Expiration:	Apr 16, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS
Patent:	⤷ Sign Up	Patent Expiration:	Jun 30, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS RHYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF

Expired US Patents for NDA 022425

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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