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Purple Book
Database of Licensed Biological Products

Product Details for: Adynovate
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)AdynovateRx
002For InjectionIntravenous2000IUSingle-Dose Vial351(a)AdynovateRx
003For InjectionIntravenous250IUSingle-Dose Vial351(a)AdynovateRx
004For InjectionIntravenous500IUSingle-Dose Vial351(a)AdynovateRx
005For InjectionIntravenous1500IUSingle-Dose Vial351(a)AdynovateRx
006For InjectionIntravenous750IUSingle-Dose Vial351(a)AdynovateRx
007For InjectionIntravenous3000IUSingle-Dose Vial351(a)AdynovateRx

Proper Name
Antihemophilic Factor (Recombinant), PEGylated

BLA Number
125566

Applicant
Takeda Pharmaceuticals U.S.A., Inc.

Original Approval Date
November 13, 2015

Date of First Licensure