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Purple Book
Database of Licensed Biological Products

Product Details for: Fiasp
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous, Subcutaneous 1000UNITS/10ML (100UNITS/ML)Multi-Dose Vial351(a)FiaspRx
002Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Autoinjector351(a)FiaspRx
003Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Multi-Dose Cartridge351(a)FiaspRx
004Injection Subcutaneous160UNITS/1.6ML (100UNITS/ML)Multi-Dose Cartridge351(a)FiaspRx

Proper Name
insulin aspart

BLA Number
208751

Applicant
Novo Nordisk Inc.

Original Approval Date
September 29, 2017

Date of First Licensure