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Tresiba
insulin degludec
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tresiba
Proper name
insulin degludec
Licence type
351(a)
BLA number
203314
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Rx | November 21, 2018 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | September 25, 2015 |
| 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | September 25, 2015 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |