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Purple Book
Database of Licensed Biological Products

Product Details for: Abrilada
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
001Injection Subcutaneous40MG/0.8MLAutoinjector351(k) InterchangeableAbriladaRx
002Injection Subcutaneous40MG/0.8MLPre-Filled Syringe351(k) InterchangeableAbriladaRx
003Injection Subcutaneous20MG/0.4MLPre-Filled Syringe351(k) InterchangeableAbriladaRx
004Injection Subcutaneous10MG/0.2MLPre-Filled Syringe351(k) InterchangeableAbriladaDisc
005Injection Subcutaneous40MG/0.8MLSingle-Dose Vial351(k) InterchangeableAbriladaRx

Proper Name
adalimumab-afzb

Reference Product Proper Name

adalimumab

Reference Product Proprietary Name

Humira

BLA Number
761118

Applicant
Pfizer Inc.

Original Approval Date
November 15, 2019

Date of First Licensure