| Product Information |
|
| Registration Number |
DRP-14088
|
| Generic Name |
Tobramycin (as sulfate) + Dexamethasone
(as sodium phosphate)
|
| Brand Name |
Abradex
|
| Dosage Strength |
3 mg/1 mg (0.3% 0.1% w/v) per mL
|
| Dosage Form |
Sterile Ophthalmic
Suspension (Eye Drops)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Aminoglycoside)/Corticosteroid
|
| Packaging |
Opaque plastic bottle x 5 mL with nozzle and cap
(Box of 1's)
|
| Manufacturer |
Makcur Laboratories Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Afree Pharmaceutical Distribution Corp.
|
| Distributor |
Afree Pharmaceutical Distribution Corp.
|
| Application Type |
Initial
|
| Issuance Date |
20 June 2023
|
| Expiry Date |
20 June 2028
|