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Fiasp
insulin aspart
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Fiasp
Proper name
insulin aspart
Licence type
351(a)
BLA number
208751
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | September 29, 2017 |
| 160UNITS/1.6ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | June 21, 2023 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | September 29, 2017 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | September 24, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |