| Product Information |
|
| Registration Number |
DR-XY48527
|
| Generic Name |
Amiodarone Hydrochloride
|
| Brand Name |
Kabidarone
|
| Dosage Strength |
50 mg/mL
|
| Dosage Form |
Solution For Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I clear glass ampoule x 3 mL (Box of 5 ampoules)
|
| Manufacturer |
PT. Ethica Industri Farmasi (PT. Ethica)
|
| Country of Origin |
Indonesia
|
| Trader |
N/A
|
| Importer |
Fresenius Kabi Philippines, Inc.
|
| Distributor |
Fresenius Kabi Philippines, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
14 December 2022
|
| Expiry Date |
14 December 2027
|