Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sanofi Winthrop Industrie
sanofi-aventis U.S. LLC
571879985
Sanofi Chimie
sanofi-aventis U.S. LLC
262600765
Genzyme Corporation
sanofi-aventis U.S. LLC
050424395
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Multaq
Product Details
NDC Product Code
0024-4142Application Number
NDA022425Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
poloxamer 407Inactive
Code: TUF2IVW3M2Class: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WEClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
carnauba waxInactive
Code: R12CBM0EIZClass: IACT
DronedaroneActive
Code: JQZ1L091Y2Class: ACTIBQuantity: 400 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT