| Product Information |
DRP-13159_PI_01.pdf
|
| Registration Number |
DRP-13159
|
| Generic Name |
Amiodarone Hydrochloride
|
| Brand Name |
Amiodal
|
| Dosage Strength |
50 mg/mL (150 mg/ 3 mL)
|
| Dosage Form |
Sterile Concentrate Solution
for IV Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
3 mL USP Type I Clear Glass Ampoule (Box of 5's and 10's)
|
| Manufacturer |
Swiss Parenterals Ltd. (Block-B)
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Despina Pharma Inc.
|
| Distributor |
Despina Pharma Inc.
|
| Application Type |
Initial (correction)
|
| Issuance Date |
26 January 2023
|
| Expiry Date |
12 December 2027
|