| Product Information |
|
| Registration Number |
DRP-13296
|
| Generic Name |
Amikacin (as sulfate)
|
| Brand Name |
Ambikacin-100
|
| Dosage Strength |
50 mg/mL (100 mg/2 mL)
|
| Dosage Form |
Solution for Injection
(IM/IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I Clear glass vial with grey bromobutyl rubber stopper and aluminum flip-off seal x 2 mL (Box of 1's)
|
| Manufacturer |
Cooper Pharma Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
08 February 2023
|
| Expiry Date |
08 February 2028
|