| Product Information |
|
| Registration Number |
DRP-12809
|
| Generic Name |
Ketorolac Trometamol
|
| Brand Name |
Ophthagesic
|
| Dosage Strength |
5mg/ mL (0.5% w/v)
|
| Dosage Form |
Ophthalmic Solution (Drops)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Anti-inflammatory Agent, Non-Steroid
|
| Packaging |
5 mL white opaque LDPE bottle with white LDPE
dropper, closed with HDPE safety ring and screwed closure (Box of 1's )
|
| Manufacturer |
World Medicine Ilac Sanayi ve Ticaret A.S.
|
| Country of Origin |
Turkey
|
| Trader |
N/A
|
| Importer |
Ambicare Pharmaceuticals Inc.
|
| Distributor |
Ambicare Pharmaceuticals Inc.
|
| Application Type |
Initial
|
| Issuance Date |
07 October 2022
|
| Expiry Date |
07 October 2027
|