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Purple Book
Database of Licensed Biological Products

Product Details for: Afstyla
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001For InjectionIntravenous3000IUSingle-Dose Vial351(a)AfstylaRx
002For InjectionIntravenous1000IUSingle-Dose Vial351(a)AfstylaRx
003For InjectionIntravenous250IUSingle-Dose Vial351(a)AfstylaRx
004For InjectionIntravenous2000IUSingle-Dose Vial351(a)AfstylaRx
005For InjectionIntravenous500IUSingle-Dose Vial351(a)AfstylaRx
006For InjectionIntravenous2500IUSingle-Dose Vial351(a)AfstylaRx
007For InjectionIntravenous1500IUSingle-Dose Vial351(a)AfstylaRx

Proper Name
Antihemophilic Factor (Recombinant), Single Chain

BLA Number
125591

Applicant
CSL Behring Lengnau AG

Original Approval Date
May 25, 2016

Date of First Licensure