Product Details for: Idacio

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
40MG/0.8ML
Autoinjector
351(k) Biosimilar
Idacio
Rx
002
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(k) Biosimilar
Idacio
Rx
003
Injection
Subcutaneous
40MG/0.8ML
Single-Dose Vial
351(k) Biosimilar
Idacio
Rx
Proper Name
adalimumab-aacf
Reference Product Proper Name
adalimumab
Reference Product Properietary Name
Humira
BLA Number
761255
Applicant
Fresenius Kabi USA, LLC
Original Approval Date
December 13, 2022
Date of First Licensure
RETURN TO SEARCH RESULTS