| Product Information |
|
| Registration Number |
DRP-13047
|
| Generic Name |
Olopatadine (as hydrochloride
|
| Brand Name |
Optihist-Pat
|
| Dosage Strength |
1mg/ml (0.1% w/v)
|
| Dosage Form |
Ophthalmic Solution (Eye Drops)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antihistamine
|
| Packaging |
Low Density Polyethylene (LDPE) white opaque plastic droptainer container and nozzle with High Density Polyethylene (HDPE) screw cap x 5 mL (Box of 1's)
|
| Manufacturer |
Makcur Laboratories Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Ensight Pharmaceuticals Inc.
|
| Distributor |
Ensight Pharmaceuticals Inc.
|
| Application Type |
Initial (Re-application) (Reconstruction)
|
| Issuance Date |
22 March 2024
|
| Expiry Date |
22 November 2027
|