Product Details for: Enbrel
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
25MG
Single-Dose Vial
351(a)
Enbrel
Disc
002
For Injection
Subcutaneous
25MG
Multi-Dose Vial
351(a)
Enbrel
Rx
003
Injection
Subcutaneous
50MG/ML
Pre-Filled Syringe
351(a)
Enbrel
Rx
004
Injection
Subcutaneous
25MG/0.5ML
Pre-Filled Syringe
351(a)
Enbrel
Rx
005
Injection
Subcutaneous
50MG/ML
Single-Dose Cartridge
351(a)
Enbrel Mini
Rx
006
Injection
Subcutaneous
50MG/ML
Autoinjector
351(a)
Enbrel
Rx
007
Injection
Subcutaneous
25MG/0.5ML
Single-Dose Vial
351(a)
Enbrel
Rx
Proper Name
etanercept
etanercept
BLA Number
103795
103795
Applicant
Immunex Corporation
Immunex Corporation
Original Approval Date
November 2, 1998
November 2, 1998
Date of First Licensure