Multaq
These highlights do not include all the information needed to use MULTAQ safely and effectively. See full prescribing information for MULTAQ. MULTAQ (dronedarone) TabletsInitial U.S. Approval: 2009
Approved
Approval ID
236d4549-f44b-4677-b857-acedd10b9920
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dronedarone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3086
Application NumberNDA022425
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronedarone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (11)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
poloxamer 407Inactive
Code: TUF2IVW3M2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
DronedaroneActive
Quantity: 400 mg in 1 1
Code: JQZ1L091Y2
Classification: ACTIB
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WE
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT