Product Details for: Cyltezo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(k) Interchangeable
Cyltezo
Rx
002
Injection
Subcutaneous
20MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Cyltezo
Rx
003
Injection
Subcutaneous
10MG/0.2ML
Pre-Filled Syringe
351(k) Interchangeable
Cyltezo
Rx
004
Injection
Subcutaneous
40MG/0.8ML
Autoinjector
351(k) Interchangeable
Cyltezo
Rx
005
Injection
Subcutaneous
40MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Cyltezo
Rx
006
Injection
Subcutaneous
40MG/0.4ML
Autoinjector
351(k) Interchangeable
Cyltezo
Rx
Proper Name
adalimumab-adbm
Reference Product Proper Name
adalimumab
Reference Product Properietary Name
Humira
BLA Number
761058
Applicant
Boehringer Ingelheim Pharmaceuticals, Inc.
Original Approval Date
August 25, 2017
Date of First Licensure
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