| Product Information |
|
| Registration Number |
DRP-11588
|
| Generic Name |
Ofloxacin
|
| Brand Name |
Oplase
|
| Dosage Strength |
3mg/mL (0.3% w/v)
|
| Dosage Form |
Ophthalmic Solution
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antibacterial (Fluroquinolone)
|
| Packaging |
15 mL White LDPE Bottle Sealed with Cap x
10 mL (Net content) (Box of 1's)
|
| Manufacturer |
Skymap Healthcare Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
AMB HK Enterprises, Inc.
|
| Distributor |
AMB HK Enterprises, Inc.
|
| Application Type |
Initial (Correction)
|
| Issuance Date |
15 September 2022
|
| Expiry Date |
30 March 2027
|