Product Details for: Humira

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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
Autoinjector
351(a)
Humira
Rx
002
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(a)
Humira
Rx
003
Injection
Subcutaneous
20MG/0.4ML
Pre-Filled Syringe
351(a)
Humira
Disc*
004
Injection
Subcutaneous
40MG/0.8ML
Single-Dose Vial
351(a)
Humira
Disc*
005
Injection
Subcutaneous
10MG/0.2ML
Pre-Filled Syringe
351(a)
Humira
Disc*
006
Injection
Subcutaneous
40MG/0.4ML
Pre-Filled Syringe
351(a)
Humira
Rx
007
Injection
Subcutaneous
40MG/0.4ML
Autoinjector
351(a)
Humira
Rx
008
Injection
Subcutaneous
80MG/0.8ML
Pre-Filled Syringe
351(a)
Humira
Rx
009
Injection
Subcutaneous
80MG/0.8ML
Autoinjector
351(a)
Humira
Rx
010
Injection
Subcutaneous
20MG/0.2ML
Pre-Filled Syringe
351(a)
Humira
Rx
011
Injection
Subcutaneous
10MG/0.1ML
Pre-Filled Syringe
351(a)
Humira
Rx
Proper Name
adalimumab
BLA Number
125057
Applicant
AbbVie Inc.
Original Approval Date
December 31, 2002
Date of First Licensure
Patent List Provided
Yes
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