| Product Information |
|
| Registration Number |
DRP-13701
|
| Generic Name |
Amikacin (as sulfate)
|
| Brand Name |
Ambikacin-500
|
| Dosage Strength |
250 mg/mL (500 mg/2 mL)
|
| Dosage Form |
Solution for Injection
(I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
2 mL USP Type I clear and colorless glass vial. enclosed with grey bromobutyl rubber closure and aluminum seal with purple plastic flip-off cap (Box of 1's)
|
| Manufacturer |
Cooper Pharma Limited
|
| Country of Origin |
|
| Trader |
India
|
| Importer |
N/A
|
| Distributor |
Ambica International Corporation.
|
| Application Type |
Initial
|
| Issuance Date |
29 March 2023
|
| Expiry Date |
29 March 2028
|