Product Details for: Abrilada 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 | Autoinjector | 351(k) Interchangeable | Abrilada | Rx |
002 | Injection | Subcutaneous | 40MG/0.8ML | Pre-Filled Syringe | 351(k) Interchangeable | Abrilada | Rx |
003 | Injection | Subcutaneous | 20MG/0.4ML | Pre-Filled Syringe | 351(k) Interchangeable | Abrilada | Rx |
004 | Injection | Subcutaneous | 10MG/0.2ML | Pre-Filled Syringe | 351(k) Interchangeable | Abrilada | Disc |
005 | Injection | Subcutaneous | 40MG/0.8ML | Single-Dose Vial | 351(k) Interchangeable | Abrilada | Rx |
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