Product Details for: Hadlima

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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(k) Interchangeable
Hadlima
Rx
002
Injection
Subcutaneous
40MG/0.8ML
Pre-Filled Syringe
351(k) Interchangeable
Hadlima
Rx
003
Injection
Subcutaneous
40MG/0.8ML
Single-Dose Vial
351(k) Interchangeable
Hadlima
Rx
004
Injection
Subcutaneous
40MG/0.4ML
Autoinjector
351(k) Interchangeable
Hadlima
Rx
005
Injection
Subcutaneous
40MG/0.4ML
Pre-Filled Syringe
351(k) Interchangeable
Hadlima
Rx
006
Injection
Subcutaneous
80MG/0.8ML
Autoinjector
351(k) Interchangeable
Hadlima
Rx
Proper Name
adalimumab-bwwd
Reference Product Proper Name
adalimumab
Reference Product Properietary Name
Humira
BLA Number
761059
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
July 23, 2019
Date of First Licensure
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