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Purple Book
Database of Licensed Biological Products

Product Details for: Cyltezo
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/0.8MLPre-Filled Syringe351(k) InterchangeableCyltezoRx
002Injection Subcutaneous20MG/0.4MLPre-Filled Syringe351(k) InterchangeableCyltezoRx
003Injection Subcutaneous10MG/0.2MLPre-Filled Syringe351(k) InterchangeableCyltezoRx
004Injection Subcutaneous40MG/0.8MLAutoinjector351(k) InterchangeableCyltezoRx
005Injection Subcutaneous40MG/0.4MLPre-Filled Syringe351(k) BiosimilarCyltezoRx
006Injection Subcutaneous40MG/0.4MLAutoinjector351(k) BiosimilarCyltezoRx

Proper Name
adalimumab-adbm

Reference Product Proper Name

adalimumab

Reference Product Proprietary Name

Humira

BLA Number
761058

Applicant
Boehringer Ingelheim Pharmaceuticals, Inc.

Original Approval Date
August 25, 2017

Date of First Licensure