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FDA Approval

Multaq

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

FDA Approval Summary

Company
Effective Date
December 28, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dronedarone(400 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

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
54868-3086
Application Number
NDA022425
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
December 28, 2011
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