| Product Information |
|
| Registration Number |
DRP-15435
|
| Generic Name |
Amiodarone Hydrochloride
|
| Brand Name |
Amiodasaph
|
| Dosage Strength |
50 mg/mL (150 mg/3 mL)
|
| Dosage Form |
Solution For Injection (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antiarrhythmic
|
| Packaging |
USP Type I Clear Glass Ampoule in PVC Tray (Box of 5's, 6's, and 10's)
|
| Manufacturer |
Kilitch Drugs India Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Ollen Pharma Trading Inc.
|
| Distributor |
Ollen Pharma Trading Inc.
|
| Application Type |
Initial
|
| Issuance Date |
09 July 2024
|
| Expiry Date |
09 July 2029
|