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Purple Book
Database of Licensed Biological Products

Product Details for: Eloctate
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 InjectionIntravenous1500IUSingle-Dose Vial351(a)EloctateRx
002For InjectionIntravenous1000IUSingle-Dose Vial351(a)EloctateRx
003For InjectionIntravenous2000IUSingle-Dose Vial351(a)EloctateRx
004For InjectionIntravenous3000IUSingle-Dose Vial351(a)EloctateRx
005For InjectionIntravenous750IUSingle-Dose Vial351(a)EloctateRx
006For InjectionIntravenous500IUSingle-Dose Vial351(a)EloctateRx
007For InjectionIntravenous250IUSingle-Dose Vial351(a)EloctateRx
008For InjectionIntravenous5000IUSingle-Dose Vial351(a)EloctateRx
009For InjectionIntravenous6000IUSingle-Dose Vial351(a)EloctateRx
010For InjectionIntravenous4000IUSingle-Dose Vial351(a)EloctateRx

Proper Name
Antihemophilic Factor (Recombinant), Fc Fusion protein

BLA Number
125487

Applicant
Bioverativ Therapeutics, Inc.

Original Approval Date
June 6, 2014

Date of First Licensure