Multaq

Lowers the risk of hospitalization for atrial fibrillation. NDA 22425, held by Sanofi Aventis US. Dronedarone Hydrochloride.

As of Nov 13, 2026, NDA 22425 (Multaq), held by Sanofi Aventis US, was first approved by FDA on Jul 1, 2009, with 23 approved supplements and 0 published complete response letters.

First approved: Jul 1, 2009
Review: Priority
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MULTAQ is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Oct 23, 2023	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Jul 1, 2009	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
MultaqEQ 400MG BASE · tablet;oral	Dronedarone Hydrochloride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 23, 2023	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Oct 23, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 16, 2020	Supplement 29Labeling · Standard review	Approved	Label Letter
Feb 12, 2016	Supplement 27REMS	Approved	Letter
Mar 31, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 19, 2014	Supplement 26Manufacturing · Priority review	Approved	None posted
Mar 19, 2014	Supplement 24REMS	Approved	None posted
Mar 19, 2014	Supplement 22REMS	Approved	Letter
Jan 30, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 27, 2013	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 7, 2012	Supplement 18Labeling	Approved	Label Letter
Sep 7, 2012	Supplement 17REMS	Approved	Label Letter
Sep 7, 2012	Supplement 16Labeling	Approved	Label Letter
Jun 13, 2012	Supplement 14REMS	Approved	Label Letter
Jan 25, 2012	Supplement 2Labeling	Approved	Label Letter
Dec 19, 2011	Supplement 13Labeling	Approved	Letter Label
Aug 22, 2011	Supplement 12Labeling	Approved	Label Letter
Aug 5, 2011	Supplement 6REMS	Approved	Letter
Jun 21, 2011	Supplement 10Labeling	Approved	Label Letter
Mar 11, 2011	Supplement 7Labeling	Approved	Letter Label
Feb 11, 2011	Supplement 5Labeling	Approved	Letter
Feb 11, 2011	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 31, 2011	Supplement 4Labeling	Approved	Letter Label
Jul 1, 2009	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22425
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters