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Awiqli
insulin icodec-abae
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Awiqli
Proper name
insulin icodec-abae
Licence type
351(a)
BLA number
761326
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,050UNITS/1.5ML (700UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | March 26, 2026 |
| 2,100UNITS/3ML (700UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | March 26, 2026 |
| 700UNITS/ML | Injection | Subcutaneous | Autoinjector | Rx | March 26, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |