| Product Information |
|
| Registration Number |
DRP-042
|
| Generic Name |
Amiodarone hydrochloride
|
| Brand Name |
Cordarone
|
| Dosage Strength |
50 mg/mL (150 mg/3 mL)
|
| Dosage Form |
Solution for Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
-
|
| Packaging |
Colorless Type I Glass Ampoule x 3 mL (6 ampoules placed in a white plastic tray) [Box of 6's]
|
| Manufacturer |
Sanofi S.r.l.
|
| Country of Origin |
Italy
|
| Trader |
N/A
|
| Importer |
Sanofi-Aventis Philippines, Inc.
|
| Distributor |
N/A
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
17 January 2024
|
| Expiry Date |
17 January 2029
|