Product Details for: Cyltezo Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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 | 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) Biosimilar | Cyltezo | Rx |
006 | Injection | Subcutaneous | 40MG/0.4ML | Autoinjector | 351(k) Biosimilar | Cyltezo | Rx |
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