| Product Information |
|
| Registration Number |
DRP-13498
|
| Generic Name |
Amikacin (as sulfate)
|
| Brand Name |
Amikacy-125
|
| Dosage Strength |
125 mg/mL
|
| Dosage Form |
Solution for Injection (I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
2 mL Type I clear and colorless glass vial enclosed with gray bromobutyl rubber stopper and aluminum seal with white plastic flip-off cap (Box of 1's)
|
| Manufacturer |
Hiral Labs Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Bellus Life Solutions, Inc.
|
| Distributor |
Bellus Life Solutions, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
28 February 2023
|
| Expiry Date |
28 February 2028
|