Product Details for: Tremfya

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
100MG/ML
Pre-Filled Syringe
351(a)
Tremfya
Rx
002
Injection
Subcutaneous
100MG/ML
Autoinjector
351(a)
Tremfya
Rx
003
Injection
Subcutaneous
200MG/2ML (100MG/ML)
Autoinjector
351(a)
Tremfya
Rx
004
Injection
Subcutaneous
200MG/2ML (100MG/ML)
Pre-Filled Syringe
351(a)
Tremfya
Rx
005
Injection
Intravenous
200MG/20ML (10MG/ML)
Single-Dose Vial
351(a)
Tremfya
Rx
006
Injection
Subcutaneous
100MG/ML
Autoinjector
351(a)
Tremfya
Rx
Proper Name
guselkumab
BLA Number
761061
Applicant
Janssen Biotech, Inc.
Original Approval Date
July 13, 2017
Date of First Licensure
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