MedPath
FDA Approval

Multaq

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dronedarone(400 mg in 1 1)

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
55154-8104
Application Number
NDA022425
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 15, 2022
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Code: JQZ1L091Y2Class: ACTIBQuantity: 400 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
poloxamer 407Inactive
Code: TUF2IVW3M2Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WEClass: IACT
carnauba waxInactive
Code: R12CBM0EIZClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
© Copyright 2025. All Rights Reserved by MedPath