| Product Information |
|
| Registration Number |
BR-573
|
| Generic Name |
Factor VIII Purified (Human)
|
| Brand Name |
Alphanate
|
| Dosage Strength |
100 IU/mL (500 IU/mL)
|
| Dosage Form |
Lyophilized Powder for Injection (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Blood Coagulation Factors
|
| Packaging |
Type I glass vial + 5 mL Type I glass pre-filled
syringe (Hypak SCF Becton-Dickinson syringe) Water for Injection as diluent + Accessories (vial adapter (syringe vial), infusion set and two (2) alcohol swabs]
|
| Manufacturer |
Grifols Biologicals, LLC
|
| Country of Origin |
U.S.A
|
| Trader |
N/A
|
| Importer |
GB Distributors, Inc.
|
| Distributor |
GB Distributors, Inc.
|
| Application Type |
Renewal
|
| Issuance Date |
20 October 2024
|
| Expiry Date |
12 October 2029
|