| Product Information |
|
| Registration Number |
DRP-13635
|
| Generic Name |
Gentamicin (as sulfate)
|
| Brand Name |
Gentamite
|
| Dosage Strength |
40 mg/mL (80 mg/ 2 mL)
|
| Dosage Form |
Solution for Injection (I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I clear colourless glass ampoule x 2 mL (Box of 10's)
|
| Manufacturer |
Swiss Parenterals Ltd. (Block-B)
|
| Country of Origin |
|
| Trader |
India
|
| Importer |
N/A
|
| Distributor |
Applied Pharmaceutical Distribution, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
21 March 2023
|
| Expiry Date |
21 March 2028
|