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Afrezza
insulin human
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Afrezza
Proper name
insulin human
Licence type
351(a)
BLA number
022472
Applicant
Mannkind Corporation
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 12UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | April 17, 2015 |
| 4UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | June 27, 2014 |
| 8UNITS/INH | Powder | Inhalation | Single-Dose Cartridge | Rx | June 27, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |