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Purple Book
Database of Licensed Biological Products

Product Details for: Kovaltry
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 InjectionIntravenous1000IUSingle-Dose Vial351(a)KovaltryRx
002For InjectionIntravenous250IUSingle-Dose Vial351(a)KovaltryRx
003For InjectionIntravenous2000IUSingle-Dose Vial351(a)KovaltryRx
004For InjectionIntravenous3000IUSingle-Dose Vial351(a)KovaltryRx
005For InjectionIntravenous500IUSingle-Dose Vial351(a)KovaltryRx

Proper Name
Antihemophilic Factor (Recombinant), Full Length

BLA Number
125574

Applicant
Bayer HealthCare LLC

Original Approval Date
March 16, 2016

Date of First Licensure