 
                        | Product NDC: | 53360-4142 | 
| Proprietary Name: | Multaq | 
| Non Proprietary Name: | dronedarone | 
| Active Ingredient(s): | 400 mg/1 & nbsp; dronedarone | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, FILM COATED | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 53360-4142 | 
| Labeler Name: | Sanofi Winthrop Industries | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022425 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20090701 | 
| Package NDC: | 53360-4142-0 | 
| Package Description: | 22750 TABLET, FILM COATED in 1 DRUM (53360-4142-0) | 
| NDC Code | 53360-4142-0 | 
| Proprietary Name | Multaq | 
| Package Description | 22750 TABLET, FILM COATED in 1 DRUM (53360-4142-0) | 
| Product NDC | 53360-4142 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | dronedarone | 
| Dosage Form Name | TABLET, FILM COATED | 
| Route Name | ORAL | 
| Start Marketing Date | 20090701 | 
| Marketing Category Name | NDA | 
| Labeler Name | Sanofi Winthrop Industries | 
| Substance Name | DRONEDARONE | 
| Strength Number | 400 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Antiarrhythmic [EPC] |