| Product Information |
|
| Registration Number |
DRP-11068
|
| Generic Name |
Amiodarone (As Hydrochloride)
|
| Brand Name |
Tachyrone
|
| Dosage Strength |
50 mg/mL (150 mg/3 mL)
|
| Dosage Form |
Solution for Injection (I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antiarrhythmic
|
| Packaging |
USP Type I Amber Glass Vial with Grey Bromobutyl
Rubber Stopper Sealed with Aluminum Flip-off Seal with Red Button x 3 mL (net content) (Box of 6's)
|
| Manufacturer |
Gland Pharma Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Biocare Lifesciences, Inc.
|
| Distributor |
Biocare Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
21 January 2022
|
| Expiry Date |
21 January 2027
|