| Product Information |
|
| Registration Number |
DR-XY48378
|
| Generic Name |
Ioversol
|
| Brand Name |
Optiray 300
|
| Dosage Strength |
636 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 [Rx] (Correction)
|
| Issuance Date |
04 October 2023
|
| Expiry Date |
03 October 2027
|