| Product Information |
|
| Registration Number |
DRP-14880
|
| Generic Name |
Ofloxacin
|
| Brand Name |
Ofloxasaph-INF
|
| Dosage Strength |
3 mg/mL (0.3% w/v)
|
| Dosage Form |
Ophthalmic Solution (Eye Drops)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Fluoroquinolone)
|
| Packaging |
5 mL white HDPE dropper bottle with plastic nozzle and
plastic cap (Box of 1's)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
31 January 2024
|
| Expiry Date |
31 January 2029
|