| Product Information |
|
| Registration Number |
DR-XY48379
|
| Generic Name |
Ioversol
|
| Brand Name |
Optiray 320
|
| Dosage Strength |
678 mg/mL
|
| Dosage Form |
Solution For Intravascular Injection
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Radiopaque Contrast Medium
|
| Packaging |
50 mL Type I Clear Glass Vial with Bromobutyl
Stopper and Aluminum Cap (Box of 10's and 25's) 100 mL Type I Clear Glass Vial with Bromobutyl Stopper and Aluminum Cap (Box of 10's and 12's)
|
| Manufacturer |
Liebel-Flarsheim Company LLC
|
| Country of Origin |
United States of America
|
| Trader |
N/A
|
| Importer |
Fernando Medical Enterprises, Inc.
|
| Distributor |
Fernando Medical Enterprises, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
30 September 2022
|
| Expiry Date |
30 September 2027
|