| Product Information |
|
| Registration Number |
BR-80
|
| Generic Name |
Factor VIII
|
| Brand Name |
Koate DVI
|
| Dosage Strength |
50 I.U./mL (250 I.U./15 mL)
|
| Dosage Form |
Lyophilized Powder for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Glass vial + SWFI diluent x 5 mL + filter needle +
double-ended transfer needle + administration set (Box of l's)
|
| Manufacturer |
Grifols Therapeuitcs, Inc.
|
| Country of Origin |
U.S.A
|
| Trader |
N/A
|
| Importer |
GB Distributors, Inc.
|
| Distributor |
GB Distributors, Inc.
|
| Application Type |
-
|
| Issuance Date |
18 March 2022
|
| Expiry Date |
07 March 2026
|