PHPMaker 2020
Human Drugs
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Human Drugs
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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
-
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
-
Issuance Date
25 March 2022
Expiry Date
12 October 2024
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