| Product Information |
|
| Registration Number |
DRP-11458
|
| Generic Name |
Tobramycin (as sulfate) + Dexamethasone (as sodium
phosphate)
|
| Brand Name |
Tobrasaph-Dex
|
| Dosage Strength |
3 mg/1 mg (0.3% w/v / 0.1 % w/v) per mL
|
| Dosage Form |
Ophthalmic Suspension (Drops)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Aminoglycoside)/Corticosteroid
|
| Packaging |
10 mL White LDPE Bottle with Nozzle and Cap x 5 mL
(net content) (Box of 1's)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
15 March 2022
|
| Expiry Date |
15 March 2027
|