| Product Information |
|
| Registration Number |
DRP-15484
|
| Generic Name |
Amiodarone Hydrochloride
|
| Brand Name |
Saphridarone
|
| Dosage Strength |
200 mg
|
| Dosage Form |
Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiarrythmic Agent
|
| Packaging |
Alu/PVC Blister Pack x 10's (Box of 100's)
|
| Manufacturer |
Sapphire Lifesciences Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
Shree Sainath International
|
| Importer |
Ollen Pharma Trading Inc.
|
| Distributor |
Ollen Pharma Trading Inc.
|
| Application Type |
Initial (Re-Application)
|
| Issuance Date |
16 July 2024
|
| Expiry Date |
16 July 2029
|