Product Details for: Tresiba
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Tresiba
Rx
002
Injection
Subcutaneous
600UNITS/3ML (200UNITS/ML)
Autoinjector
351(a)
Tresiba
Rx
003
Injection
Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Tresiba
Rx
Proper Name
insulin degludec
insulin degludec
BLA Number
203314
203314
Applicant
Novo Nordisk Inc.
Novo Nordisk Inc.
Original Approval Date
September 25, 2015
September 25, 2015
Date of First Licensure